This disclosure relates to a medical test and more specifically to a test protocol for assessing a patient""s pancreatic response to natural and electrical stimulation.
The medical device industry produces a wide variety of electronic and mechanical devices for treating patient medical conditions. Depending upon medical condition, medical devices can be surgically implanted or connected externally to the patient receiving treatment. Clinicians use medical devices alone or in combination with drug therapies and surgery to treat patient medical conditions. For some medical conditions, medical devices provide the best, and sometimes the only, therapy to restore an individual to a more healthful condition and a fuller life. One type of medical device that can be used to treat pancreatic conditions is a neurostimulator. Neurostimulator treatment for pancreatic conditions involves placing electrical leads typically within the gastrointestinal tract of a patient and applying an electrical signal with an implanted or external neurostimulator. When considering whether neurostimulation would be suitable to treat a condition in a patient, patient testing is helpful.
Pancreatic testing is challenging because the pancreas is a complex organ with a multitude of functions and many pancreatic conditions manifest themselves indirectly through symptoms that may not initially be attributed to a pancreatic condition. Pancreatic testing is also challenging because the pancreas is not a static organ that secretes at a constant rate. Pancreatic secretion varies in response to a variety of factors that may stimulate or decrease pancreatic secretions. Some conditions attributable to pancreatic dysfunction are: pancreatitis, diabetes, inflammation of the pancreas, malabsorbtion syndrome, and certain cancers. In addition to these conditions, there are a variety of other conditions that may be attributable to pancreatic dysfunction such as pain, nausea, and vomiting.
Previous pancreatic diagnostic tests are static and involve measuring one or more pancreatic function indicators and then correlating the measurements to measurements expected for various types of pancreatic disease. An example such static pancreatic testing is described in the following publication: Frank Netter, xe2x80x9cThe Ciba Collection of Medical Illustrationsxe2x80x9d, Vol. 3 Digestive System, Part III Liver, Billary Tract And Pancreas (1964). Static testing does not evaluate pancreatic response to stimulation so some pancreatic conditions may not be identified.
For the foregoing reasons, there is a need for a pancreatic test that evaluates pancreatic response to stimulation. Additionally, pancreatic testing in response to stimulation would provide additionally information that would be helpful in selecting a therapy such as electrical stimulation to treat a pancreatic condition and avoid inappropriate therapies, so patients"" benefit from decreased risk of medical complications, reduced pain, more rapid treatment, and reduced costs.
A screening test is used on a patient to determine if pancreatic secretion is responsive to stimulation. The screening test compares measurements of a pancreatic indicator both before and after natural stimulation. The pancreatic indicator is measured before natural stimulation and then the patient""s pancreas is naturally stimulated. After waiting a time period from when the natural stimulation began, the pancreatic indicator is once again measured. The difference between the pancreatic indicator measured before ingesting the meal and the pancreatic response indicator measured after ingesting and waiting a time period is calculated and a decision is made whether the patient has a pancreatic condition suitable for treatment with electrical stimulation.
In one version of the invention, an efficacy test is used to evaluate the efficacy of employing electrical stimulation to treat a pancreatic condition. The efficacy test compares a pancreatic response indicator before electrical stimulation and after electrical stimulation to decides whether there is efficacy in using electrical stimulation to treat a patient""s pancreatic condition. In other version of the invention, an efficacy test is used to evaluate the efficacy of using electrical stimulation to treat nausea and vomiting.